NCT03448172

Brief Summary

The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]PF-05221304 in Healthy Adult Male Subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

February 7, 2018

Last Update Submit

December 3, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Mass Balance

    Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered

    0-96 hr

Secondary Outcomes (12)

  • Metabolic profiling for PF-05221304 in plasma, urine, and feces

    0-96 hr

  • Radioactivity AUClast

    0-96 hr

  • Plasma PF-05221304 AUClast

    0-96 hr

  • Radioactivity AUCinf

    0-96 hr

  • Plasma PF-05221304 AUCinf

    0-96 hr

  • +7 more secondary outcomes

Study Arms (1)

Investigational Product

EXPERIMENTAL

\[14C\]PF-05221304

Drug: [14C]PF-05221304

Interventions

[14C]PF-05221304DRUG

a single oral dose of \[14C\]PF-05221304 (50 mg/100 µCi liquid formulation)

Investigational Product

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages of 18 and 45 years, inclusive.
  • Body mass index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
  • Total body weight \> 50 kg (110 lb).

You may not qualify if:

  • \. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 27, 2018

Study Start

April 18, 2018

Primary Completion

May 26, 2018

Study Completion

June 13, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Locations

US(1)